FDA Organizational and Technological Transformation

Highlights from Axendia’s FDA e-Transformation Study – Part II

By Daniel R. Matlis

In this series of articles, we are sharing key insights and conclusions from the “FDA e-Transformation Initiatives” research study.  

We began the “FDA e-Transformation” series by sharing our interview with Dr. Armando Oliva, FDA Deputy Director for Bioinformatics, to understand the Agency’s rationale and strategy for e-Transformation.  We also discussed how the FDA is pursuing a future where all regulated product information is electronic.

(To read the first article in the series, click on this link: FDA Pursuing a Future Where All Regulated Product Information Is Electronic )

In this installment of the “FDA e-Transformation” series, we highlight four key findings from this study:

  • FDA’s e-Transformation drivers
  • A new organizational e-Structure
  • Don’t want to pave the cow-path
  • Building  on a strong foundation: open-consensus based data standards

FDA’s e-Transformation drivers

Historically, interactions between FDA and the companies it regulates involved the creation, printing and delivery of volumes of paper documents. These documents may have been delivered as part of an application or reviewed onsite in the course of an inspection.

Over the last few years, FDA and the industry have recognized the need for a modern, well-integrated, reliable, efficient and affordable electronic information infrastructure to support FDA administrative, regulatory and business operations.

A new organizational e-Structure

At the center of the agency’s e-transformation is the “Bioinformatics Board” (BiB).

The FDA established the BIB in order to achieve its goal for a modern, well-integrated, reliable, efficient and affordable information infrastructure to support the Agency’s administrative and regulatory business operations.

The BiB reports directly to the FDA Management Council.  The Board, in coordination with the Office of Information Management (OIM) determines the information management (IM) strategy for the agency.





BioInformatics Board


  •  The BiB works under a strategic framework for automation established by the Commissioner and implemented by the FDA Management Council. 
  • The BiB coordinates and oversees all activities and decisions related to business automation planning, acquisition, and implementation throughout FDA, and ensure that the activities related to its charge are communicated to all levels of the Agency.
  • The BiB also ensures coordination of activities among FDA representatives particularly with regard to business process planning and regulatory policies. These include the FDA Regulation Policy Council, the FDA Data Standards Council, and the Enterprise Architecture Review Board,.  The BIB also interacts with other federal health informatics initiatives such as the Federal Health Architecture program.

“We don’t want to pave the cow-path”…

…“The real promise of Electronic Review lies beyond simply receiving submissions in electronic format” commented Donna-Bea Tillman, Ph.D, Director of the Office of Device Evaluation CDRH.

The Agency is poised to provide a new target Enterprise Architecture (EA). This Target EA will provide a business-driven plan that describes the desired end-state for the FDA’s business architecture, data architecture, applications architecture, technical architecture, security architecture, and standards profile.

The primary purpose of the Target EA is to effectively plan a course for achieving the FDA’s strategic vision and goals. It is one element in a broader set of interrelated activities that collectively enable the FDA managers and staff to define a vision, develop strategies and plans for achieving the vision, make resource decisions, implement strategies and evaluate performance.

By defining the end-state from several distinctive perspectives (e.g. business, data, etc.), the Target EA will also provide stakeholders with a view into the complex relationships that exist among these different perspectives.

Building on a strong foundation: open-consensus based data standards

The FDA recognizes the importance of, and is committed to using open-consensus based data standards for regulatory submissions.






FDA divides data standards into two broad categories: exchange standards and terminology standards.  

  • Exchange standards provide a consistent way to exchange information between organizations and computer systems. Exchange standards help ensure that the sending and the receiving system both understand unambiguously what information is being exchanged. For example, Structured Product Labeling (SPL) is an exchange standard for product information.
  • Terminology standards, on the other hand, provide a consistent way to describe concepts. For example, the Unique Ingredient Identifiers (UNII), developed by FDA, provides a consistent way to describe substances in foods and drugs.

The agency is putting its money, where its mouth is

In November 2008, the FDA announced the award of up to $2.5 Billion in contracts to Modernize Information Technology over the next ten years. This award supports the cornerstone of FDA’s Information Technology and Bioinformatics initiatives, which include extensive IT modernization programs encompassing data management, data warehousing, IT infrastructure and IT security.

The benefits of FDA’s e-transformation could be “game changing”. Imagine conducting a label negotiation in real-time with FDA review staff, being able to cooperate and mark up documents in real time, or the possibility of reviewing SOPs and Batch record electronically with an investigator.

The “FDA e-Transformation Initiatives” research study was made possible by a contribution from MasterControl Inc.

To schedule a briefing detailing findings and analysis on our finding, please contact us at info@axendia.com   

Findings and detailed analysis from this study will be presented at the INTERPHEX PharmaMedDevice Symposium scheduled for March 19, 2009 at 9:00AM (Session PMD14) at the Jacob K. Javits Convention Center in NY.


Copyright 2009 Axendia, Inc. All Rights Reserved.
No Portion of this publication may be duplicated or redistributed in any form without approval from Axendia.

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